Antengene Corporation Limited has announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody, for the treatment of B cell related autoimmune diseases.
ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body’s own immune system for precise and potent action. Antengene plans to initiate and advance the phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia.
The ATTRACT study will be led by Zhanguo Li from Peking University People’s Hospital as the principal investigator. This is a phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, immunogenicity, preliminary efficacy of ATG-201.
Zhanguo Li said: “It is a great honour to lead the first-in-human (FIH) trial of Antengene’s investigational drug ATG-201. Significant unmet clinical needs remain in patients with refractory B cell‑mediated autoimmune diseases, including low remission rates, high relapse risk, and long‑term safety concerns. ATG‑201, a dual CD3/CD19 T‑cell engager, redirects and activates autologous T cells to achieve precise elimination of pathogenic B cells—a novel mechanism that may overcome current therapeutic limitations. Our team, in close collaboration with the sponsor, Antengene, will rigorously conduct this phase I study to evaluate the safety and preliminary efficacy.”
Antengene and UCB have entered into an agreement that grants UCB a worldwide exclusive license to develop, manufacture, and commercialise ATG-201, along with access to its associated manufacturing technology. Antengene will conduct the FIH phase I clinical trials in China and Australia, and thereafter transfer all further clinical development activities to UCB.
To date, Antengene has obtained 33 investigational new drug (IND) approvals in the US and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO (selinexor), is approved in China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (China, Taiwan, Australia, South Korea and Singapore).